A Phase 1, Open-Label, Multicenter Study of INCA033989 in Participants With Myeloproliferative Neoplasms

Description

This study is being conducted to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered in participants with myeloproliferative neoplasms.

Trial Eligibility

Inclusion Criteria: * Life expectancy \> 6 months. * Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease). * Existing documentation from a qualified local laboratory of CALR exon-9 mutation. * Participants with MF or ET as defined in the protocol. Exclusion Criteria: * Presence of any hematological malignancy other than ET, PMF, or post-ET MF. * Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment. * Participants with laboratory values exceeding the protocol defined thresholds. * Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned. * Active invasive malignancy over the previous 2 years. * History of clinically significant or uncontrolled cardiac disease. * Active HBV/HCV or known history of HIV. * Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment. * Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any time within 4 weeks before the first dose of study treatment. Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study Info

Interventions

Locations Recruiting

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